BEUDAMED
    FDA Registration Active 🇨🇳 China

    Blood Pressure Cuff

    Reg #: 3009349165 · FEI: 3009349165 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MIRA MEDSOURCE (SHANGHAI) CO., LTD.
    Registration Number
    3009349165
    FEI Number
    3009349165
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    UnitA, 23F, HuaXinHaiXin Building, 666 FuZhou Road, Huangpu District
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K191209

    Owner / Operator

    Firm Name
    Mira MEDsource (Shanghai) Co., Ltd.
    Operator Number
    10039008
    Address
    UnitA,23F, HuaXinHaiXin Building, 666 FuZhou Road, Huangpu District
    City
    Shanghai
    State
    CN-SH
    Postal Code
    200001
    Country
    CN
    Correspondent
    Tina Tian

    US Agent

    Business Name
    O&M Halyard, Inc.
    Contact Name
    Angela Bunn
    Address
    1 Edison Drive
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US
    Email
    [email protected]
    Phone
    470 3647147

    Products

    Device Name Product Code
    Blood Pressure Cuff DXQ

    Proprietary Names

    Blood Pressure Cuff

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device